Functional Drink Gut Health Clinical Trial and Research Services

A gut health functional drink is a beverage that contains ingredients related to the digestive system, such as probiotics, prebiotics, dietary fiber or postbiotics, in the form of fermented milk, ready-to-drink beverages or powders for mixing. A clinical trial for drinks in this group compares gastrointestinal symptoms and bowel habits between people who drink the test beverage and people who drink a placebo beverage, using standard assessment tools that do not require blood draws.

The market for probiotic and gut-balance health drinks continues to grow, including fermented milk, drinks with added beneficial microorganisms and drinks with added prebiotic fiber, and consumers are paying more and more attention to gut health. Brand owners who want to communicate about gut health on labels or in marketing materials need scientific evidence to support those statements, and food advertising must comply with the Food Act B.E. 2522 (1979), including advertising approval where the law requires it.

A key advantage of clinical research for drinks in this group is that gut health outcomes can be assessed reliably with standard symptom questionnaires and diaries, which participants can report or complete without blood draws or other invasive methods (non-invasive). VISBIO Co., Ltd. provides study design, project management and project coordination for clinical studies of gut health functional drinks, in collaboration with a network of partner clinical research sites and hospitals, from protocol planning to the final report, under Good Clinical Practice (GCP), for sponsors in Thailand and abroad.

Under the Food Act B.E. 2522 (1979), the Thai Food and Drug Administration (Thai FDA) authorizes drinks mainly on the basis of product safety and quality; authorization does not confirm that a drink affects gut balance, the digestive system or the number of beneficial microorganisms as communicated in marketing. The food registration number (Thai FDA number) on the label is therefore not evidence of those effects, and communicating about gut balance or bowel habits without supporting evidence risks breaching food advertising law.

At the same time, some modern trade buyers, distributors and export partners have begun to ask for supporting scientific documents for gut health drinks, and better-informed consumers wonder whether gut health statements on labels are “actually measurable”.

A clinical study that uses standard tools to assess gastrointestinal symptoms builds empirical evidence directly, by comparing symptoms and gut health outcomes between a group receiving the test drink and a group receiving a placebo drink, under conditions controlled according to GCP. The data support product development and evidence-based communication.

Gut health drinks contain several groups of ingredients: probiotics, which are live microorganisms that confer a health benefit on the consumer when taken in adequate amounts; prebiotics, which are substances selectively utilized by gut microorganisms; and synbiotics, which combine both groups in one formula. These ingredients are made into ready-to-drink beverages that are convenient to consume.

Chaiyasut et al. (2022) conducted a randomized, double-blind, placebo-controlled study in 48 older Thai adults who received a multi-strain probiotic or a placebo for 12 weeks, and found significant changes in intestinal permeability, obesity-related body composition indices and some metabolic markers. This work shows that clinical studies of gut health products can be carried out systematically in Thai participants. The endpoints in that study were measured from urine, blood and stool samples, whereas the service on this page focuses mainly on non-invasive assessment tools.

The main outcome assessment tools in studies of gut health drinks are non-invasive, such as the Gastrointestinal Symptom Rating Scale (GSRS) developed by Svedlund et al. (1988) and the Bristol Stool Form Scale (BSFS), for which Lewis and Heaton (1997) showed that changes in stool form can reflect changes in intestinal transit time. Both tools are accepted and widely used in clinical research on the digestive system.

Every study follows GCP and takes into account the particular nature of non-invasive gut health assessment, which relies on standard symptom questionnaires and diaries. VISBIO designs the study and manages it from planning to delivery of the report, while volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.

Step 1: Consultation and protocol design

Together with the investigators of a partner research site, VISBIO reviews the drink’s characteristics, the effects the sponsor wants to claim and the purpose of the product, in order to define a suitable study plan, including the choice of a primary endpoint for gut health. This step covers setting inclusion and exclusion criteria that fit the claim, and estimating a sample size with adequate statistical power.

Step 2: Approval from the human research ethics committee

Before any data are collected, the protocol and the informed consent documents must in every case be approved by a human research ethics committee (Institutional Review Board: IRB). VISBIO coordinates document preparation with the site’s investigators and follows up on revisions requested by the committee until approval is granted.

Step 3: Volunteer recruitment and screening

Once approval is granted, the research site responsible for the study recruits and screens volunteers according to the protocol. The site’s physicians and investigators make sure that every volunteer receives complete information, gives written consent and passes a health screening before joining the study. VISBIO coordinates schedules and study readiness between the sponsor and the research site.

Step 4: Study conduct and data collection

Volunteers receive the test drink or the placebo drink, and data are collected at the time points set in the protocol, using standard assessment tools accepted in clinical research, such as a gastrointestinal symptom rating scale, a stool form chart, a daily gastrointestinal symptom diary and a tolerability questionnaire, together with recording of adverse events throughout the study. The site’s investigators assess the volunteers and look after their safety, while VISBIO, as project manager, monitors progress and the completeness of the data.

Step 5: Data analysis and reporting

All data are analyzed statistically according to a statistical analysis plan (SAP) set in advance and summarized in a complete scientific report in an internationally used format. VISBIO coordinates the analysis and delivers the report to the sponsor. The report supports product development and evidence-based communication.

This service is designed for health drinks in various formats that aim to communicate about gut and digestive health. Examples of suitable ingredient types and product formats are shown below.

Evidence from a clinical study is not just a regulatory document. It is a strategic asset that owners of probiotic and gut health drink brands can use to create value in several ways.

Premium product positioning

A drink with clinical study data can be positioned in the premium segment on a reasoned and credible basis. In a market with many low-priced probiotic drinks, GSRS or BSFS outcomes measured in the group that received the test drink, compared with a control group, give the product’s value proposition a data foundation and set it apart from competitors without such data.

Negotiations with modern trade and e-commerce channels

Many e-commerce platforms and modern trade buyers in the health category ask for supporting scientific documents. A clinical study report prepared under GCP makes negotiations and product listing in these channels smoother.

Lower legal risk and expansion into export markets

Gut health statements that are supported by clinical study evidence reduce the risk that advertising will be considered exaggerated under the Food Act B.E. 2522 (1979). In addition, a study designed and reported to international practice is part of preparing to enter export markets, and each country has its own requirements.

Using scientific data in marketing communication

Data actually measured in a clinical study can be used across several communication channels. Advertising use, however, requires proper advertising approval from the Thai FDA before publication, as required by law.

1. Drinks sold in Thailand must already have a food registration number (Thai FDA number) before the study starts. For products of sponsors from abroad, VISBIO assesses the legal conditions together with the research site on a project-by-project basis.
2. VISBIO and the research site design the study plan specifically for each product and its claim.
3. Every study must be approved by a human research ethics committee before it starts, without exception.

For brands that want evidence at every level, VISBIO supports work from initial activity testing at the cellular level (In Vitro) through to clinical studies in volunteers. GCP applies to studies in humans, while laboratory work follows the test method for each assay. Planning every level of evidence with a single coordinator keeps the data from each stage consistent and leaves no gaps.

What is a gut health functional drink?

It is a beverage that contains ingredients related to the digestive system, such as probiotics, prebiotics, dietary fiber, synbiotics or postbiotics, in the form of fermented milk, ready-to-drink beverages or powders for mixing.

Does a drink’s Thai FDA number confirm effects on gut health?

No. Thai FDA authorization under the Food Act is based mainly on product safety and quality. If you want to communicate about gut health, clinical data provide supporting evidence, and advertising must still comply with food law.

Does the study require blood draws?

The main assessment tools for this service are non-invasive: the Gastrointestinal Symptom Rating Scale (GSRS), the Bristol Stool Form Scale (BSFS), a daily symptom diary and a tolerability questionnaire, so no blood draws are needed.

What are the GSRS and the BSFS?

The GSRS is a gastrointestinal symptom rating scale developed by Svedlund et al. (1988). The BSFS is a stool form chart, for which Lewis and Heaton (1997) showed that changes in stool form can reflect changes in intestinal transit time. Both tools are widely used in clinical research on the digestive system.

What is VISBIO’s role in a study, and who looks after the volunteers?

VISBIO designs the study and provides project management and coordination in collaboration with a network of partner clinical research sites and hospitals. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.

Do study results guarantee advertising approval?

No. Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.

If you are interested in clinical research for your gut health functional drink, contact VISBIO for a free initial consultation through any of these channels:

• Contact form: https://visbio.co.th/en/contact-us/
• LINE Official Account: @visbio
• Email: service@visbio.co.th
• Phone: 098-635-4197
• Timeline: please ask our team directly.

See all clinical trial services on VISBIO’s clinical trial service page.

• VISBIO’s role: VISBIO designs studies and provides project management and project coordination in collaboration with a network of partner clinical research sites and hospitals, for sponsors in Thailand and abroad. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.
• Research ethics: Every study in humans starts only after approval by a human research ethics committee and is conducted under Good Clinical Practice (GCP). Every volunteer signs an informed consent form after receiving complete information.
• Drugs and herbal medicines: Studies must follow the Thai FDA requirements that apply to the product. The sponsor, the research site and VISBIO plan these steps together from the start of the project.
• Use of results: Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law for each product type, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.
• Foods and dietary supplements: Study results are not a claim that a product diagnoses, treats, cures, mitigates or prevents any disease.
• Timeline: This depends on the study design and the approval process. Please ask our team directly.

References:

1. Chaiyasut, C., Sivamaruthi, B. S., Lailerd, N., Sirilun, S., Khongtan, S., Fukngoen, P., Peerajan, S., Saelee, M., Chaiyasut, K., Kesika, P., & Sittiprapaporn, P. (2022). Probiotics supplementation improves intestinal permeability, obesity index and metabolic biomarkers in elderly Thai subjects: A randomized controlled trial. Foods, 11(3), 268. https://doi.org/10.3390/foods11030268
2. Lewis, S. J., & Heaton, K. W. (1997). Stool form scale as a useful guide to intestinal transit time. Scandinavian Journal of Gastroenterology, 32(9), 920–924. https://doi.org/10.3109/00365529709011203
3. Svedlund, J., Sjödin, I., & Dotevall, G. (1988). GSRS—A clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Digestive Diseases and Sciences, 33(2), 129–134. https://doi.org/10.1007/BF01535722